- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00235820
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis (CHAMPION)
July 15, 2008 updated by: Abbott
A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
271
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Abbott Park, Illinois, United States, 60064
- Global Medical Information-Abbott
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- Male subjects must hve been vasectomized or practicing birth control.
Exclusion Criteria:
- Previous systemic anti-TNF therapy.
- Prior use of MTX.
- Known hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids during the study.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
40 mg every other week following an 80 mg dose
Other Names:
|
Active Comparator: B
|
MTX 7.5 to 25 mg once weekly
|
Placebo Comparator: C
|
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Time Frame: Week 16
|
Week 16
|
Safety parameters
Time Frame: Every Study Visit
|
Every Study Visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physician Global Assessment
Time Frame: Baseline - Week 16
|
Baseline - Week 16
|
PASI 50/90/100
Time Frame: Baseline - Week 16
|
Baseline - Week 16
|
DLQI
Time Frame: Baseline - Week 16
|
Baseline - Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Medical Information, Abbott
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
July 17, 2008
Last Update Submitted That Met QC Criteria
July 15, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M04-716
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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